BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces that a class action lawsuit has been filed in the United States District Court for the District of Colorado on behalf of purchasers of the securities of Venaxis, Inc. (“Venaxis” or the “Company”) (NASDAQ:APPY) between March 13, 2014 and January 28, 2015, inclusive (the “Class Period”).
Venaxis develops and commercializes products for unmet diagnostic and therapeutic needs. The Company’s lead product candidate is APPY1 − a blood-based diagnostic test designed to aid in the evaluation of patients for acute appendicitis. The Complaint alleges that defendants made false and/or misleading statements and/or failed to disclose that: (1) the APPY1 test failed to meet the criteria for “substantial equivalence” based upon data and information submitted by Venaxis in its 510(k) premarket submission to the U.S. Food and Drug Administration; (2) the Company lacked a reasonable basis to conclude that the results from the APPY1 pivotal study were sufficient to support FDA clearance; and as a result of the foregoing, (3) Venaxis’ public statements pertaining to the expected FDA clearance of its 510(k) were materially false and misleading at all relevant times.
On January 29, 2015, the Company announced that the FDA has determined that the Company’s appendicitis test was not found to be substantially equivalent to the standard of care. According to the Company, the FDA determined that “the APPY1 Test does not meet the criteria for substantial equivalence based upon data and information submitted by Venaxis in its 510(k) submission.” Following this news, Venaxis shares dropped more than 73%, or $1.49 per share, to close at $0.55 on January 29, 2015, on extremely heavy volume.
If you are a member of the Class described above, you have until April 3, 2015, to move the Court to serve as lead plaintiff, if you meet certain legal requirements. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you wish to learn more about this action, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, Toll Free at (888) 638-4847, or by email to firstname.lastname@example.org, or visit our website at http://www.howardsmithlaw.com.